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What must be written on a Maryland script for a controlled substance
Executive Summary
Maryland law requires controlled-substance prescriptions to meet both statutory issuing rules and technical form restrictions: prescribers must generally electronically prescribe controlled dangerous substances (CDS) since January 1, 2022, but exceptions allow handwritten, oral, or out-of-state paper prescriptions in narrowly defined circumstances, and when paper is used Maryland law and regulations impose form, content, and dispensing limits [1] [2] [3]. The statutes and regulations emphasize legitimacy, separate prescriptions per controlled substance, and pharmacist due diligence, while deferring some precise content requirements to federal rule 21 CFR §1306 and implementing Maryland regulations [4] [2].
1. Why Maryland pushed electronic prescribing — and the carve-outs that matter now
Maryland moved to mandatory electronic prescribing for controlled substances to reduce diversion and fraud, with the requirement effective January 1, 2022; the statute still preserves limited exceptions for technological failure, temporary waivers, or prescriptions intended for out-of-state dispensing [1] [5]. The law’s practical effect is that most CDS scripts will be created in an e-prescribing system tied to the Prescription Drug Monitoring Program and prescriber registration processes, but pharmacists remain authorized to accept handwritten or oral prescriptions only when the statutory exceptions apply, and they must apply due diligence to verify legitimacy before dispensing [1] [5]. This creates a two-track reality: routine electronic workflows and an exception path that triggers extra pharmacist scrutiny.
2. What Maryland explicitly restricts on paper prescription forms
Maryland statutes and older code language require that if a paper prescription is used for a controlled substance it must be on a separate form for each substance and may not be preprinted with the drug’s name, quantity, or strength, and the prescription must be legible and attributable to an authorized prescriber [3] [2]. The rule to avoid preprinted drug fields is aimed at preventing bulk or template-fueled misuse; each controlled substance must be documented individually so pharmacists file and audit each authorization separately. Those provisions remain referenced in Maryland’s statute text and in state regulatory guidance, though modern practice increasingly layers e-prescribing requirements on top of these older paper-era constraints [2] [3].
3. Commonly required content on a CDS prescription — state and federal overlap
Maryland’s regulations cross-reference federal controlled-substance prescription elements in 21 CFR §1306, so in practice a valid CDS prescription must contain identification of the prescriber (including DEA registration when applicable), patient name, drug name and strength, quantity to be dispensed, directions for use, date of issue, and signature or authenticated electronic equivalent [4] [2]. The state adds time limits — most controlled-substance scripts must be filled within 120 days of issue — and requires that prescriptions be issued for a legitimate medical purpose within a prescriber’s professional practice [2]. Pharmacists must ensure these elements are present and may refuse to dispense if due diligence raises concerns about authenticity [2] [1].
4. Pharmacist responsibilities and filing requirements that change practice
When a pharmacist receives an oral CDS prescription, Maryland law requires the pharmacist to promptly reduce it to writing and file a separate prescription record for each controlled substance, mirroring the paper-form restriction and creating an auditable trail [3]. For both written and electronic prescriptions, pharmacists must confirm prescriber authorization and legitimacy, query the PDMP as required, and comply with refill and dispensing limitations; dispensing a controlled substance without these safeguards can lead to the drug being treated as misbranded or to regulatory discipline [2] [6]. This framework shifts significant gatekeeping responsibility onto pharmacists, especially when prescriptions arrive outside standard electronic channels.
5. Where ambiguity remains and what to check now
Maryland statutes and regulations provide a clear policy direction but leave operational detail to implementing rules and federal cross-references, creating ambiguities about exact form fields, signature formats for hybrid systems, and handling of out-of-state scripts [4] [2]. Practitioners should consult the current Maryland Code Section 21-220, COMAR provisions referenced by the state (including electronic-prescribing guidance), and 21 CFR §1306 for the precise list of required elements, and monitor PDMP and CDS registration pages for updates; recent state guidance tied to the January 2022 electronic-prescribing mandate is particularly relevant [4] [1]. For compliance, the safest course is to use compliant e-prescribing systems, ensure separate documentation per controlled substance, and verify prescriber DEA and PDMP query records when prescriptions fall outside electronic norms [1] [2].